Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Filing Receipt and Priority
The filing receipt mailed 01/22/2025 states that the instant application is a 371 of PCT/US2022/040874, filed 08/19/2022, which claims benefit of provisional application 63/235,455, filed 08/20/2021. The provisional application supports the instant claims. Therefore the effective filing date is 08/20/2021.
Information Disclosure Statements
The information disclosure statements submitted 02/12/2024 and03/17/2025 have been considered.
Restriction/Species Election
Applicant’s election of Group I, claims 1-17 is acknowledged. Applicant’s election of the following species is also acknowledged.
At examiner’s discretion, search and examination has been broadened to include all compounds of claim 6. Claims 4 and 5 are rejoined for examination.
Objections
There are two “X” limitations in claim 1, as shown below.
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Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-2, 6, 8, 11-12, 14-15, and 17 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Dictenberg (US2019/0201381).
Dictenberg in para. [0033] points to Fig. 4A-B and discloses that a hippocampal neuron cells were placed in a cryopreservation solution of its invention. The solution is disclosed to include 3,6-dibromo-alpha-(piperazinylmetyhl-2,4-imidazolidinedione), structure shown below, in a concentration of 5 nM. Cell viability was measured at 71% after 7 days.
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Dictenberg in para. [0034] points to Fig. 5 which discloses the freezing process to avoid damaging cells which includes preserving the biological material to temperatures between 0 to -20oC.
Dictenberg in Example 11 discloses the effect of cryopreservation solution of its invention on liver cell activity.
Dictenberg in para. [0033] states “the 3-reagent cryopreservation solution was perfused into a living pregnant mouse briefly just minutes before the pups were isolated from the dam, and then the hippocampal neurons isolated from the E18 (embryonic day 18) pups.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
KSR Rationales
The MPEP in section 2143, subsection I gives examples of Rationales for supporting a conclusion of obvious. These rationales are non-exhaustive and include (A) Combining prior art elements according to known methods to yield predictable results; (B) Simple substitution of one known element for another to obtain predictable results; (C) Use of known technique to improve similar devices (methods, or products) in the same way; (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results; (E) “Obvious to try” – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Claim(s) 1-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over obvious over Dictenberg (cited above) and Gavathiotis (WO 2018165494).
Regarding claims 1-2, 6, 8, 11-12, 14-15, and 17, discussion of Dictenberg from the 102 rejection above is incorporated here.
Dictenberg does not teach compounds of structures found in instant claims 3-5. This is addressed by the combination of Gavathiotis.
Regarding claims 3-5 and 7, Gavathiotis on p. 8-11 teaches BAX inhibitors which share significant structural similarities with the BAX inhibitor of Dictenberg. The compounds listed are:
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Considering the similarities, and the fact that Dictenberg’s BAX inhibitor is the first compound shown, one of ordinary skill in the art would find it obvious to use any of the compounds above in place of the BAX inhibitor of Dictenberg in Dictenberg’s cryopreservation solution.
Regarding claims 9-10, which are drawn to effective amounts ‘such that the biological material remains substantially viable” for periods of 72 hours and/or 14 days, one of ordinary skill would find it obvious to elucidate the amount needed. The instant specification states “a biological material that is ‘substantially viable’ includes, but is not limited to the organ, tissue or population of cells, that when stored, maintained, and/or transported in one or more of the compositions disclosed herein, that are at least about 95% viable, at least about 96% viable, at least about 97% viable, at least about 98% viable, or even at least about 99% viable.” The claim language suggest that “effective amount” sufficient to effect the 95+% viability can be determined via routine research and optimization. That is, one of ordinary skill in the art would find it obvious to modify the concentration, dose, or total amount of BAX inhibitor within the Dictenberg solution to achieve the desired effect.
Similarly, regarding claim 16, one of ordinary skill would find it obvious to modify the concentration of the BAX inhibitor to be from about 1 to 20 μg/mL.
Regarding claim 13, which is drawn to an embodiment of the method of claim 1 wherein the biological material is harvested within a certain period of time (about 2 to about 10 hours) after a preceding period of ischemic injury, the instant specification, regarding “ischemic injury, states in para. [0076] that “A preceding period of warm ischemic injury refers to a period of reduced or no blood flow within the organ or tissue between when life support is withdrawn from the donor and death is declared. The period may range from about 1 minute to about 24 hours, from about 1 hour…”.
Dictenberg discusses cell and tissue dissection. This process involves killing of the test subject mice (ischemic injury). One of ordinary skill would find it obvious to apply the method of cryopreservation from Dictenberg within the time period claimed in instant claim 13 as it would be within the skillset of one of ordinary skill to determine when tissue, cell, or organ samples can be preserved.
Dictenberg teaches a method of cryopreservation comprising administration of BAX inhibitor with structure that embraces the instant compounds. Gavathiotis teaches a number of other BAX inhibitors that are alternatives to the BAX inhibitor of DIctenberg. One of ordinary skill would find it obvious to replace the BAX inhibitor of Dictenberg with any of the compounds of Gavathiotis to arrive at the instant claims.
Therefore, it would have been prima facie obvious at the time of the effective filing date for one of ordinary skill in the art to have modified the method of Dictenberg to instead administer any of the compounds of Gavathiotis instead. One of ordinary skill would find motivation to make the
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Patent 12,708,621
Claims 1-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 12,708,621 in view of Dictenberg (cited above) and Gavathiotis (cited above).
The reference patented claims are drawn to methods of treating a disease and/or conditions associated with dysregulation of apoptosis mediated by BAX comprising administering compounds of the following structures:
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.
Gavathiotis indicates that the compounds above are BAX inhibitors. Dictenberg teaches a method of cryopreservation comprising administering a BAX inhibitor. One of ordinary skill would be able to modify the method of Dictenberg to use any of the compounds above from the reference claims.
Patent 11,938,128
Claims 1-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 11,938,128 in view of Dictenberg (cited above) and Gavathiotis (cited above).
The reference claims are drawn to compounds of the following structures:
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Gavathiotis indicates that the compounds above are BAX inhibitors. Dictenberg teaches a method of cryopreservation comprising administering a BAX inhibitor. One of ordinary skill would be able to modify the method of Dictenberg to use any of the compounds above from the reference claims.
Pertinent Art not Cited
Bailly-Maitre (PNAS, 2006, vol. 103, no. 8, 2809-2814) reports on the potential of inhibiting BAX using the anti-apoptotic protein BI-1 (BAX inhibitor 1) for cryopreservation.
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LUISALBERTO GONZALEZ whose telephone number is (571)272-1154. The examiner can normally be reached M-F 8:30-5:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Murray can be reached at (571) 272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LUISALBERTO GONZALEZ/Examiner, Art Unit 1624
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